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. 2010 Nov 16;153(10):655-7.
doi: 10.7326/0003-4819-153-10-201011160-00008.

Streamlining ethical review

Joseph Millum  1 , Jerry Menikoff
Affiliations

Streamlining ethical review

Joseph Millum et al. Ann Intern Med. .

Abstract

The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.

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References

    1. Levine RJ. Editorial: Institutional Review Boards: A Crisis in Confidence. Ann Intern Med. 2001 Jan 16;134(2):161–163. - PubMed
    1. Satel S. Clinical Trials, Wrapped in Red Tape. New York Times. 2009 Aug 8;:A19.
    1. Fost N, Levine RJ. The Dysregulation of Human Subjects Research. JAMA. 2007;298(18):2196–2198. - PubMed
    1. Menikoff J. Where’s the Law? Uncovering the Truth About IRBs and Censorship. Northwestern University Law Review. 2007;101(2):791–799.
    1. Gunsalus C, Bruner E, Burbules N, Dash L, Finkin M, Goldberg J, et al. The Illinois White Paper: Improving the System for Protecting Human Subjects: Counteracting IRB Mission Creep. Qualitative Inquiry. 2007;13:617–649.

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